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Quidel Gets EUA for Rapid, Extraction-Free COVID-19 MDx on Solana System

NEW YORK – Quidel Corporation announced Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for a rapid molecular diagnostic test for SARS-CoV-2 on the firm's benchtop Solana instrument.

Called the Solana SARS CoV-2 assay, the 25-minute test was cleared for moderately complex settings under CLIA. It uses nasopharyngeal and nasal swab specimens in viral transport media collected from patients suspected of COVID-19 infection.

The Solana instrument uses the firm's proprietary isothermal helicase-dependent amplification. It performs testing on 11 samples with minimal hands-on time, and does not require any extraction. In a statement, Quidel noted that there are more than 1,000 Solana instruments currently in the market.

The small-profile instrument has a touchscreen, barcode scanner, Ethernet and USB ports, and comes with access to the firm's Virena data management ecosystem, which enables reporting of aggregated, de-identified testing data to public health authorities.

"Solana is a powerful diagnostic solution at a critical time," said Quidel CEO Doug Bryant. "With so many of our nation's laboratories overwhelmed by demand for COVID-19 tests and under pressure to produce more timely results, there is a compelling societal need for the throughput and quick runtime offered by our new Solana molecular testing technology."

Bryant noted on the firm's most recent call with investors that data generated by the Solana SARS-CoV-2 assay showed "remarkable agreement" with extracted PCR.

The other menu for the Solana instrument currently includes 10 assays for Bordetella, Clostridium difficile, Group A Strep, Group B Strep, a combined test for herpes simplex 1 and 2 as well as varicella zoster virus, influenza A and B, a combined test for respiratory syncytial virus and human metapneumovirus, a Strep complete assay for different strains of Strep A, trichomonas, and a respiratory viral panel.

The Solana EUA marks the sixth the firm has now received to detect the SARS-CoV-2 virus. It has commercialized three PCR-based molecular kits in its Lyra line, two antigen tests on its Sofia system, and received EUA earlier this week for a readerless rapid antigen test on its QuickVue platform.